EDF Health

“Illegal, unscientific, and un-health protective”: Summing up EPA’s final methylene chloride risk evaluation

Richard Denison, Ph.D.is a Lead Senior Scientist.

Today, the Trump EPA released its first final risk evaluation and determination under the reformed Toxic Substances Control Act (TSCA), for the carcinogenic and acutely lethal chemical methylene chloride.

Sadly, despite EPA’s rush to issue this document as the 4th anniversary of TSCA reform on June 22 approaches, EPA doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA has grossly and systematically underestimated the exposures to and risks of methylene chloride.  Read More »

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EPA’s own words reveal what its new chemicals program has become – a captive of industry

Richard Denison, Ph.D.is a Lead Senior Scientist.

“The agency’s goal is to allow the commercialization of products,” said EPA associate deputy assistant administrator for new chemicals Lynn Dekleva.

Readers of this blog know that EDF is no fan of how the Trump EPA has implemented – in our view, twisted – the 2016 reforms made to the review process for new chemicals under the Toxic Substances Control Act (TSCA).  Decision after decision over the last 3.5 years under this administration has undercut public health and benefitted industry interests, despite some noble efforts by career staff to chart a better course.  In recent weeks the Trump EPA’s intentions have been even more clearly revealed, thanks to the trade press’s reporting of EPA political appointees’ comments delivered to industry audiences.  That’s what this post is about.  Read More »

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Reveal News exposes Trump Administration’s disregard for protecting the public from a highly dangerous chemical: 5 key takeaways

Richard Denison, Ph.D.is a Lead Senior Scientist.

This weekend, Elizabeth Shogren at Reveal News published an in-depth investigative report and hour-long radio segment delving into the Trump EPA’s latest abandonment of science and its serious consequences for public health.  The story focuses on the ubiquitous solvent trichloroethylene (TCE), a known human carcinogen and neurotoxicant that is also linked to birth defects at very low levels of exposure.

In reforming the Toxic Substances Control Act (TSCA) in 2016, Congress directed EPA to conduct comprehensive reviews of the risks posed by TCE and other widely used chemicals.  EPA was charged with identifying risks both to the general public and to “vulnerable subpopulations,” including pregnant women, infants, workers, and others.

EPA’s draft risk evaluation of TCE was released on February 21.  It suffers from many of the same gaping flaws as do EPA’s draft risk evaluations for other chemicals.  Once again, EPA has utterly failed to carry out the clear intent of the law, putting our health at greater risk.

  • EPA has ignored all exposures of the general population to TCE that arise from releases of the chemical to air, water and land – amounting to millions of pounds annually.
  • EPA has once again assumed, without any supporting data, that workers will wear personal protective equipment and that it will be effective in eliminating or reducing exposures.
  • EPA has inflated the acceptable level of risk of cancer that will allow workers to be exposed to as much as 100 times more of the chemical.

“This decision is grave. It not only underestimates the lifelong risks of the chemical, especially to the developing fetus, it also presents yet another example of this administration bowing to polluters’ interests over public health.”

Dr. Jennifer McPartland

But in this new draft EPA has gone even further in abandoning both science and the law.  Reveal’s exposé identifies key changes made at the 11th hour to the draft that were forced on career staff at the agency by the White House.

Here are five key takeaways from the Reveal story:  Read More »

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EPA’s draft risk evaluation of carbon tetrachloride is riddled with unsupported exclusions and assumptions

Richard Denison, Ph.D.is a Lead Senior Scientist.

Next week, the Scientific Advisory Committee on Chemicals (SACC), established under the Toxic Substances Control Act (TSCA) to peer-review EPA’s draft chemical risk evaluations, will meet to review the latest of those drafts, for the likely human carcinogen carbon tetrachloride.

As with other recent draft risk evaluations, EPA has been scheduling the SACC meetings in the middle of rather than following the public comment period.  This means the public has at best a few weeks to digest these huge documents and draft and submit comments in order to have them be part of the record that the SACC is allowed to take into consideration in its peer review.

However, we have learned that EPA is now further constraining the SACC’s schedule, requesting that the panel members come to the peer review meeting with their comments already drafted, and then delivering their final report within 60 days rather than the 90 days previously provided.  These developments further jam both the public and the SACC in their efforts to ensure EPAs work is subject to a robust peer review.

Whatever the reasons for EPA making these changes, EDF decided to expedite our initial comments to seek to ensure they could be considered.  We submitted comments last week, a full week before the February 19 deadline, to ensure the SACC received and had sufficient time to review them in advance of the peer review meeting.

We deemed this critical because of the glaring gaps and flaws in EPA’s draft that lead it yet again to drastically understate the risks of this chemical.  These include the same problems that have plagued the draft risk evaluations for other chemicals, as well as new ones.  Read More »

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While harder to discern, another EPA risk evaluation severely understates risk, this time for methylene chloride

Richard Denison, Ph.D.is a Lead Senior Scientist.

When EPA released the draft of its risk evaluation for methylene chloride at the end of last month, some were surprised that EPA had identified numerous unreasonable risks presented under a variety of the chemical’s conditions of use.

In an earlier post, EDF provided some context, noting how dangerous the chemical is and raising initial concerns that EPA was once again excluding known uses and exposures, making unsupported assumptions, and applying inappropriate risk benchmarks that were once again leading it to significantly understate the actual risks posed by methylene chloride.

Four weeks later, EDF has confirmed these concerns in spades.  Last night we filed 84 pages of comments on the draft risk evaluation, for consideration by EPA’s Scientific Advisory Committee on Chemicals (SACC), which will meet next week to peer review the draft.

EDF’s deep dive into the draft demonstrates that EPA has employed a host of unwarranted and unsupported assumptions and methodological approaches that lead it to either avoid identifying unreasonable risk when it should have, or to understate the extent and magnitude of the unreasonable risks it did identify.  Below we summarize some of the major concerns, which are addressed in detail in our comments.  Read More »

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EPA’s just-released methylene chloride draft risk evaluation: Some important context

Richard Denison, Ph.D.is a Lead Senior Scientist.

After more than a month’s delay, EPA today released its draft risk evaluation for methylene chloride.  Running to 725 pages (not counting more than a dozen supplemental files), it will take some time to digest.  But here are some initial observations that provide context for those of you who will be looking closer.

First, methylene chloride is a very nasty chemical.  It has killed a lot of people.  It causes cancer.  Short- and long-term exposure to it is tied to liver effects, immune system effects, nervous system effects, and reproductive/developmental effects.

So it shouldn’t be surprising that EPA’s draft – even coming from an administration not known to be overly worried about the risks of chemicals – has found that most industrial, commercial and consumer uses of methylene chloride present unreasonable risks.

For example, EPA found that workers using methylene chloride-based paint strippers face high risks.  Of course, we knew that already:  EPA identified those risks more than five years ago, and proposed to ban those uses.  This EPA decided it had to do it all over again – which means that thousands of workers have continued to be unnecessarily exposed to this deadly chemical.  And it will be even more years before we get back to where we were before EPA took its mulligan.

So the good news is that EPA seems to be acknowledging that methylene chloride presents high enough risks to warrant regulation under the Toxic Substances Control Act (TSCA).

The bad news is that EPA is dramatically underestimating the magnitude of methylene chloride’s risks – by pulling the same tricks it has for other chemicals among the first 10 it is evaluating under TSCA:

  • EPA once again ignores all exposures and risks to the general population by falsely assuming those exposures and risks are eliminated by actions it has taken or could take under other laws. That means ignoring over 4 million pounds of methylene chloride annually released to air, water and land.  See this backgrounder for the details and why this EPA assumption about methylene chloride is deeply flawed.
  • EPA once again grossly understates risks to workers:
    • EPA assumes that workers will always wear fully effective personal protective equipment (respirators and gloves) to make many of the risks it identifies go away – and to grossly understate the magnitude of the unreasonable risks it does find.
    • EPA once again finds a cancer risk to workers unreasonable only if it exceeds a level of 1 in 10,000 – which is 100 times higher a risk than warrants regulation under TSCA to protect workers and other vulnerable subpopulations.
    • For occupational non-users (ONUs), EPA has once again failed to identify unreasonable risks for the most highly exposed, and hence most vulnerable, workers unless it finds that the majority of workers also face unreasonable risks.

These are just a few initial observations based on our reading of EPA’s opus so far.

So while it’s somewhat encouraging that this new draft risk evaluation has found many more risks than previous drafts, we can already tell the draft falls far short of adequately describing the risks presented by methylene chloride.

Stay tuned.

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